FDA Asked Big Pharma to Self-Police on Dangerous Chemicals

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Many colorful medicinesYou can guess how that worked out. Action Alert!

Phthalates are synthetic chemicals used in plastics, lubricants, insect repellants, nail polish, perfumes, and, yes, even in prescription drugs.

Phthalates are also:

In 2012, reacting to criticism, the FDA released a “Guidance for Industry” on limiting the use of dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) in pharmaceutical drugs. (A Guidance is exactly that—a nonbinding recommendation by the FDA for industry to comply with agency-suggested, but completely voluntary, standards.)

Essentially, the 2012 guidance lists the plethora of health issues associated with phthalates, and then politely asks drug companies not to use DBP or DEHP in their drugs. This is despite the fact that the FDA has full power to ban phthalates and—in the text of the guidance—admits that “exposure to DBP and DEHP from pharmaceuticals presents a potential risk of developmental and reproductive toxicity” and “safer alternatives are available.”

Two years later, the response from Big Pharma is about what you’d expect. On the upside, Prilosec, despite its numerous other faults, no longer contains phthalates, nor does generic theophylline. On the downside, Asacol, a drug for ulcerative colitis produced by Actavis Pharma, still contains DBP, as does mesalamine, the generic form of Asacol; didanosine (brand name Videx) contains DBP; and omeprazole, a generic heartburn prescription, contains DEHP. Additionally, phthalates are also present in at least fifteen other drugs.

It’s been well established that patients who take drugs containing phthalates absorb that chemical into their body: in 2008, a man became infertile after taking Asacol daily for just three months (he had 100 times more DBP in his system that the EPA considers safe). Studies have also found that the average urine concentration of DBP in mesalamine users is fifty times higher than non-users, and elevated phthalate levels are also detectable in omeprazole, didanosine, and theophylline users.

Why would the FDA issue a voluntary guidance, when they have the power to ban harmful substances outright?

The answer, as always, can be reduced to three little words: “Follow the money.” Drug companies today pay a large proportion of the FDA’s budget, and FDA career personnel may hope to work for drug companies later in their career.

Action Alert! Tell the FDA to ban phthalates in drugs! Please write to the FDA today and tell them their voluntary compliance request is not being heeded, and is not sufficient to protect Americans’ health. Please take action immediately!

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  • NJ

    We no longer have a government; what we have is a “management team” that works solely for large corporations and “management” works as “overseers” of the 350 million – 335+9, who are basically chattel slaves on one level or another; with the uppermost paid chattel “some how” believing that they have free will when all they are allowed to do, as the lower tiered chattel is to buy or not to buy cheap trash from China at expensive or low prices; it’s all the same heap of garbage worth destroying especially people of color and the planet for; to let corporations “sell you exclusively”…that’s it and that’s all; otherwise there is no difference whatsoever!!!

  • Amy Wiesner

    Self-policing isn’t realistic when money is involved.
    Make a different decision when it comes to the health US citizens and the rest of the world.

  • Alice Moriarty

    Yes! Follow the money. Then ask yourself why does FDA’s funding all come from Big Pharma? Why does congress not fund FDA to do the testing instead of merely looking at the testing that Big Pharma chooses to let the FDA see. I have a pretty strong antipathy to the FDA but there’s plenty of blame to share. As long as the taxpayer does not choose to force Congress to budget money for FDA’s mission, how would you suggest the problem be solved? “We have met the enemy and he is us!”

    • Patricia H

      Congress funds over half FDA’s budget, they do not pay for the studies or double blind test so what do they spend the millions on? As for them accepting money from pharma, stop all graft in the government. We the people let this happen, we the people need to stop it.

  • Amy H

    Isn’t this like having the fox watch the hen house….

    • Keith Koziol

      H yes it is just like”THE FOX WATCHING THE HEN HOUSE”

  • Raj Inder K khalsa

    I am unable to sign the petition as when I click on the take action button , for a brief few seconds it is up and then it switches to another page which looks like a search engine page. Not sure what is wrong.

  • Linda Stuckey

    What? The FDA wants big Pharma to VOLUNTARILY guide themselves? If that is true, then why can’t WE decide what we will accept, in the way of GMO products, for instance?
    Is the FDA not concerned about what big Pharma is putting in our ‘medicines’ either? Are you just too busy to care?

  • Jeannette

    Just one more example of the corruption that has completely taken over our government. Why would anyone expect Big Pharma to police anything they do not want to and that makes them money. Money that funds politicians and the FDA itself. Maybe the FDA has been eating too many of those chemicals themselves.

  • T. Welsh

    Everything is so blatantly about the money. The FDA’s complete disregard for life is chilling, I honestly believe the increase of aggressive totalitarian methods perpetrated on the people, is a reflection of moral deficit in our culture. These decisions reflect a view they they are “above” that they rule over us for their profit. Let us elect, the people that we want in the FDA, instead of this Drug Cartel running us.